Skip to main content
Clinical Trials/NCT05393700
NCT05393700
Unknown
N/A

Effects of Early Sleep After Action Observation Therapy on Balance in Elderly

Istituto Clinico Humanitas0 sites45 target enrollmentJune 15, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Old Age; Debility
Sponsor
Istituto Clinico Humanitas
Enrollment
45
Primary Endpoint
Changes in Four Step Square Test
Last Updated
3 years ago

Overview

Brief Summary

The study aims at investigating the effects of an early sleep window after Action Observation Therapy (AOT) on balance in elderly. Forty-five healthy-like elderly will be enrolled and randomized into 3 groups (AOT-sleep, AOT-control and Control) performing a 3-week AOT. AOT-sleep and AOT-control will be asked to watch video-clips showing motor contents before sleeping or at least 12 hours before sleeping, respectively, whereas Control will be asked to watch landascape video-clips before sleeping. Participants will be assessed before and after training and at 1 month follow-up for balance outcomes.

Registry
clinicaltrials.gov
Start Date
June 15, 2022
End Date
June 15, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Istituto Clinico Humanitas
Responsible Party
Principal Investigator
Principal Investigator

Michele Tedeschi

Principal Investigator

Istituto Clinico Humanitas

Eligibility Criteria

Inclusion Criteria

  • Ability to walk for at least 100 meters with no assistance or aids

Exclusion Criteria

  • Musculoskeletal disorders able to affect balance
  • Traumas and/or injuries and/or surgery at the level of the lower limbs, spine in the previous year
  • Sleep disorders
  • Drugs able to affect sleep
  • Dementia or cognitive decline (MCI)
  • Psychiatric or neurological disorders

Outcomes

Primary Outcomes

Changes in Four Step Square Test

Time Frame: At baseline, 3 weeks of training and 1 month after the training end

The outcome measure is aimed at investigating changes in terms of dynamic balance

Changes in Timed Up and Go Test

Time Frame: At baseline, 3 weeks of training and 1 month after the training end

The outcome measure is aimed at investigating changes in terms of mobility

Changes in Lower Quarter Y-Balance Test

Time Frame: At baseline, 3 weeks and 1 month after the training end

The outcome measure is aimed at investigating changes in terms of static balance

Changes in 10-Meter Walking Test

Time Frame: At baseline, 3 weeks of training and 1 month after the training end

The outcome measure is aimed at investigating changes in terms of gait speed

Secondary Outcomes

  • Morningness Eveningness Scale(At baseline)
  • Euro Quality of Life - 5 dimensions(At baseline)
  • Changes in center of pressure parameters(At baseline, 3 weeks of training and 1 month after the training end)
  • Changes in Fall Efficacy Scale(At baseline, 3 weeks of training and 1 month after the training end)
  • Pittsburg Quality Sleep Index(3 weeks)
  • Kinesthetic and Visual Imagery Questionnaire(At baseline)

Similar Trials